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The Long-term Effect of SAAE and Medical Treatment for Primary Aldosteronism

21. Februar 2022 aktualisiert von: First Affiliated Hospital of Chengdu Medical College

The Long-term Effect of Superselective Adrenal Arterial Embolization and Medical Treatment for Primary Aldosteronism on Cardiorenovascular Protection, Blood Pressure, and the Endocrinological Profile.

In this prospective controlled trial, we aim to determine whether superselective adrenal artery embolization is superior to medical treatment for patients with PA who refuse surgery for medication. Patients age 18 to 75 years with hypertension will be screened for the presence of PA according to Endocrine Society Clinical Practice Guidelines. Patients with confirmed PA are counseled on the treatment option, including adrenalectomy. Those who opt to enroll in the study choice either SAAE or spironolactone (20-60mg daily) therapy (medical group). In both groups, if office blood pressure exceeds 140/90mmHg, amlodipine and terazosin will sequentially be added to the initial therapy form month 1 to year 3. The primary endpoint is the change in blood pressure, and the secondary end point is the change in biochemical outcomes. The Primary Aldosteronism Surgical Outcome criteria are used to classify clinical and biochemical outcomes as complete, partial, or absent success.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

Primary aldosteronism (PA) is the main cause of secondary hypertension, affecting 5%-15% of the general hypertensive population. Early diagnosis and treatment are of crucial importance because patients with PA are more susceptible to cardiovascular morbidity and mortality than primary hypertensive patients. Traditional treatments such as medication with mineralocorticoid receptor antagonists and adrenalectomy have some limitations. Over the past decade, superselective adrenal artery embolization (SAAE) has been used to treat PA, but their efficacies have not been compared with medication-controlled studies. Recent study found that SAAE is an effective and safe treatment for patients with PA. In this prospective controlled trial, we aim to determine whether this procedure is superior to medical treatment for patients with PA who refuse surgery for medication.

Patients age 18 to 75 years with hypertension will be screened for the presence of PA according to Endocrine Society Clinical Practice Guidelines. Adrenal computed tomography will be performed in all patients. Patients willing to participate in the study also will undergo adrenal venous sampling (AVS) Serum aldosterone and renin levels are measured by chemiluminescence immunoassay. Patients with confirmed PA are counseled on the treatment option, including adrenalectomy. Those who opt to enroll in the study choice either SAAE or spironolactone (20-60mg daily) therapy (medical group). In both groups, if office blood pressure exceeds 140/90mmHg, amlodipine and terazosin will sequentially be added to the initial therapy form month 1 to year 3. The primary endpoint is the change in blood pressure, and the secondary end point is the change in biochemical outcomes. The Primary Aldosteronism Surgical Outcome Criteria are used to classify clinical and biochemical outcomes as complete, partial, or absent success.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

400

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610500

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Hypertensive patients were willing to participate and then hospitalized for further evaluation. Antihypertensive medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing. Hypertensive patients were prescribed with verapamil and/or terazosin based on Endocrine Society Clinical Practice Guideline. Patients with positive aldosterone-to-renin ratio underwent one of the following confirmatory tests: saline infusion test or captopril inhibition test. Adrenal CT scan and adrenal venous sampling (AVS) were performed for subtype classification of the PA. The PA patients were counseled on the various treatment options, including surgery, medications, and adrenal artery ablation.

Beschreibung

Inclusion Criteria:

  • Clinical diagnosis of PA
  • They refused medication treatment due to intolerance of side effects
  • They had lateralization by adrenal venous sampling (AVS), and refused the adrenalectomy

Exclusion Criteria:

  • History of serious contrast agent allergy
  • Complication with severe liver diseases
  • History of myocardial infarction and stent implantation within the past 3 months
  • Renal insufficiency, with serum creatinine >176 umo/L
  • Pregnancy or lactation
  • History of participation in another clinical trial in the past 3 months
  • Any serious comorbidity

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
SAAE group
Patients who were diagnosed with primary aldosteronism choice SAAE at our institution
MRA group
Patients who were diagnosed with primary aldosteronism choice medical treatment(mineralocorticoid receptor antagonists, MRA)) at our institution

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical outcomes-Change from Baseline Systolic Blood Pressure
Zeitfenster: at 12 months
Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication
at 12 months
Clinical outcomes-Change from Baseline Systolic Blood Pressure
Zeitfenster: at 24 months
Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication
at 24 months
Clinical outcomes-Change from Baseline Systolic Blood Pressure
Zeitfenster: at 36 months
Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication
at 36 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin
Zeitfenster: at 12 months
Complete biochemical success is defined as correction of hypokalaemia (if present pretreatment) and normalization of the aldosterone/plasma renin(ARR); in patients with a raised ARR after treatment, aldosterone secretion should be suppressed in a confirmatory test. Partial biochemical success is defined as correction of hypokalaemia (if present pre-treatment) and a raised ARR with one or both of the following (compared with pre-treatment): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-treatment confirmatory test result. Absent biochemical success is defined as persistent hypokalaemia (if present pre-treatment) or persistent raised ARR, or both, with failure to suppress aldosterone secretion with a post-treatment confirmatory test
at 12 months
biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin
Zeitfenster: at 24 months
Complete biochemical success is defined as correction of hypokalaemia (if present pretreatment) and normalization of the aldosterone/plasma renin(ARR); in patients with a raised ARR after treatment, aldosterone secretion should be suppressed in a confirmatory test. Partial biochemical success is defined as correction of hypokalaemia (if present pre-treatment) and a raised ARR with one or both of the following (compared with pre-treatment): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-treatment confirmatory test result. Absent biochemical success is defined as persistent hypokalaemia (if present pre-treatment) or persistent raised ARR, or both, with failure to suppress aldosterone secretion with a post-treatment confirmatory test
at 24 months
biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin
Zeitfenster: at 36 months
Complete biochemical success is defined as correction of hypokalaemia (if present pretreatment) and normalization of the aldosterone/plasma renin(ARR); in patients with a raised ARR after treatment, aldosterone secretion should be suppressed in a confirmatory test. Partial biochemical success is defined as correction of hypokalaemia (if present pre-treatment) and a raised ARR with one or both of the following (compared with pre-treatment): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-treatment confirmatory test result. Absent biochemical success is defined as persistent hypokalaemia (if present pre-treatment) or persistent raised ARR, or both, with failure to suppress aldosterone secretion with a post-treatment confirmatory test
at 36 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

First Affiliated Hospital of Chengdu Medical College

Ermittler

  • Studienstuhl: Yanqiu Yang, First Affiliated Hospital of Chengdu Medical College

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. April 2022

Primärer Abschluss (Voraussichtlich)

1. Januar 2025

Studienabschluss (Voraussichtlich)

1. Januar 2025

Studienanmeldedaten

Zuerst eingereicht

9. Januar 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Februar 2022

Zuerst gepostet (Tatsächlich)

2. März 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. März 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Februar 2022

Zuletzt verifiziert

1. Februar 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SAAE-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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